The Experts below are selected from a list of 285 Experts worldwide ranked by ideXlab platform
Salvatore Salomone - One of the best experts on this subject based on the ideXlab platform.
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safety profile assessment of Buflomedil an overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Filippo Drago, Laura Longo, Salvatore SalomoneAbstract:Purpose Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients <40 years of age. The indications for which these young patients were prescribed Buflomedil were not reported in most cases. Conclusions The main indication of Buflomedil is PAD; however, because most cases of IOD occurred in people <40 years of age, where PAD is unlikely, it is possible that Buflomedil was prescribed for other indications and/or that it was not directly prescribed to the end user, who rather gained access to the medication prescribed to family members or friends. Copyright © 2012 John Wiley & Sons, Ltd. key words—Buflomedil; adverse drug reaction; overdose; post-marketing surveillance; safety; pharmacoepidemiology
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Safety profile assessment of Buflomedil: An overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Luca Longo, Filippo Drago, Salvatore SalomoneAbstract:Purpose: Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods: A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results: The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients
Claudio Bucolo - One of the best experts on this subject based on the ideXlab platform.
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safety profile assessment of Buflomedil an overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Filippo Drago, Laura Longo, Salvatore SalomoneAbstract:Purpose Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients <40 years of age. The indications for which these young patients were prescribed Buflomedil were not reported in most cases. Conclusions The main indication of Buflomedil is PAD; however, because most cases of IOD occurred in people <40 years of age, where PAD is unlikely, it is possible that Buflomedil was prescribed for other indications and/or that it was not directly prescribed to the end user, who rather gained access to the medication prescribed to family members or friends. Copyright © 2012 John Wiley & Sons, Ltd. key words—Buflomedil; adverse drug reaction; overdose; post-marketing surveillance; safety; pharmacoepidemiology
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Safety profile assessment of Buflomedil: An overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Luca Longo, Filippo Drago, Salvatore SalomoneAbstract:Purpose: Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods: A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results: The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients
Giovanni Camillieri - One of the best experts on this subject based on the ideXlab platform.
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safety profile assessment of Buflomedil an overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Filippo Drago, Laura Longo, Salvatore SalomoneAbstract:Purpose Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients <40 years of age. The indications for which these young patients were prescribed Buflomedil were not reported in most cases. Conclusions The main indication of Buflomedil is PAD; however, because most cases of IOD occurred in people <40 years of age, where PAD is unlikely, it is possible that Buflomedil was prescribed for other indications and/or that it was not directly prescribed to the end user, who rather gained access to the medication prescribed to family members or friends. Copyright © 2012 John Wiley & Sons, Ltd. key words—Buflomedil; adverse drug reaction; overdose; post-marketing surveillance; safety; pharmacoepidemiology
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Safety profile assessment of Buflomedil: An overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Luca Longo, Filippo Drago, Salvatore SalomoneAbstract:Purpose: Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods: A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results: The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients
Filippo Drago - One of the best experts on this subject based on the ideXlab platform.
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safety profile assessment of Buflomedil an overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Filippo Drago, Laura Longo, Salvatore SalomoneAbstract:Purpose Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients <40 years of age. The indications for which these young patients were prescribed Buflomedil were not reported in most cases. Conclusions The main indication of Buflomedil is PAD; however, because most cases of IOD occurred in people <40 years of age, where PAD is unlikely, it is possible that Buflomedil was prescribed for other indications and/or that it was not directly prescribed to the end user, who rather gained access to the medication prescribed to family members or friends. Copyright © 2012 John Wiley & Sons, Ltd. key words—Buflomedil; adverse drug reaction; overdose; post-marketing surveillance; safety; pharmacoepidemiology
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Safety profile assessment of Buflomedil: An overview of adverse reactions between 1975 and 2011
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Claudio Bucolo, Giovanni Camillieri, Luca Longo, Filippo Drago, Salvatore SalomoneAbstract:Purpose: Review all the individualized cases of adverse drug reaction (ADR) potentially related to Buflomedil, a vasodilator with the indication for peripheral arterial disease (PAD), marketed in Europe since the 1970s but recently suspended by the European Medicines Agency. Methods: A review of all available individualised case safety data relating to oral Buflomedil from the Buflomedil global safety database (provided by the manufacturer of Buflomedil), the worldwide published medical literature, toxicology/poison centres and regulatory authorities. Results: The main ADRs reported were in the cardiovascular (CVS) and nervous systems (NS), grouped under four (MedDRA) System Organ Classes (SOCs): (i) Cardiac disorders; (ii) Vascular disorders; (iii) Investigations; (iv) NS disorders. From an initial cumulative number of 1054 case reports, there were 401 cases of intentional overdose (IOD) of which 63 were fatal, and 137 cases of accidental overdose, with two fatalities, and 516 case reports of ADRs under normal conditions of use of the product at normal therapeutic dosage with 11 fatalities. Overdosage (intentional or accidental) represented 50.9% of cases, with 47.6% of patients
Su Jian-hua - One of the best experts on this subject based on the ideXlab platform.
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Protective effects of Buflomedil on sciatic nerve crush lesion in rats
Chinese Journal of New Drugs and Clinical Remedies, 2008Co-Authors: Su Jian-huaAbstract:AIM Study on protective effects of Buflomedil to sciatic nerve crush lesion in rats.METHODS One hundred SD rats were randomly divided into normal group,model group,mecobalamin group (104μg·kg~(-1)), and Buflomedil group (40 mg·kg~(-1)).Sciatic nerve crush lesion model were established in rats.The conduction velocity of sciatic nerve and the morphological changes were observed by light and electron microscope.RESULTS At the end of 4 weeks,the conduction velocity of Buflomedil group increased obviously as well as methycobal group,with significant difference (P0.05,P0.01).Almost normal myelin was observed in the Buflomedil group and mecobalamin group,and the severe degeneration was observed in the model group.CONCLUSION Buflomedil shows recovery effects on the sciatic nerve crush lesion.
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Study on influence of Buflomedil hydrochloride to sciatic nerve crush lesion in rats
Journal of Southeast University, 2005Co-Authors: Su Jian-huaAbstract:Objective Study on protective effect of Buflomedil hydrochloride on sciatic nerve crush lesion in rats. Methods Sciatic nerve crush lesion mode are established in rats, then protection effect of Buflomedil hydrochloride on sciatic nerve crush lesion was investigated by observing the conducting speed of crushed sciatic nerve as well as measuring interphalangeal distance of foot by foot print analysis. Results Buflomedil hydrochloride obviously recovered the sciatic crush lesion in rats. [WT5HZ]Conclusion Buflomedil hydrochloride can recover the sciatic nerve crush lesion.
